NCT02432313

Brief Summary

Parts 1 and 2: Subjects take 1 dose of various formulations of the study product, and provide samples for pharmacokinetic (PK) analysis after each, with at least 7 days between doses. Part 3: Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and provides samples for PK analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

April 28, 2015

Last Update Submit

October 30, 2015

Conditions

Pharmacokinetics of Anatabine

Outcome Measures

Primary Outcomes (1)

  • PK measures of blood anatabine

    0-2 hrs (every 15 min); 2-6 hrs (every 30 min); 6-12 hr (every 60 min); at 18, 24, 36, and 48 hr

Secondary Outcomes (1)

  • reported adverse events or serious adverse events

    immediately post-dose to 5-days post-dose

Other Outcomes (1)

  • measures of pro-inflammatory mediators from stimulated peripheral blood mono-nuclear cells

    pre-dose to 12 hours post-dose

Study Arms (1)

Modified Release Formulation x (MRx)

EXPERIMENTAL

Various formulations of Modified Release anatabine citrate tablets

Drug: Modified Release Formulation x (MRx)

Interventions

Modified Release Formulation x (MRx)DRUG

Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation

Modified Release Formulation x (MRx)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • negative for urinary cotinine
  • normal test values for liver function
  • provide informed consent

You may not qualify if:

  • clinically significant abnormal biochemistry, hematology, or urinalysis, as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

  • Sharan Sidhu, MBChB, MRCS

    Quotient Clinical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 4, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

GB(1)